FeverACTUGA2NCT01048801
Role and Effectiveness of Rapid Diagnostic Tests in Home-based Management of Malaria
A study testing Rapid diagnostic test and presumptive malaria treatment in people with Fever and Malaria, run by DBL -Institute for Health Research and Development at 1 site in Uganda.
Trial summary
Most malaria deaths occur within 48 hours of onset of symptoms, and in rural areas with poor access to health facilities, home management of malaria (HMM) can improve the timeliness of treatment and reduce malaria mortality by up to 50%. Read more about this study
- Who is it for?
- Ages 5 to 59 months
- What is being tested?
- Rapid diagnostic test and presumptive malaria treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteUganda
- Study dates
- Mar 2010to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged between 6 months and 5 years (< 5 years)reported with fever by the mother/ caretaker of the child
- Children with uncomplicated malaria/ fever episodes
- Children whose mothers consent to participate
Who cannot join
- Children aged less 6 months or greater than 4 years (≥ 5 years)
- Children requiring referral to a health facility (severe malaria, complicated fever episode, convulsions/fits, loss of consciousness, and other danger signs)
- Children whose mothers refuse to consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role and Effectiveness of Rapid Diagnostic Tests in Home-based Management of Malaria: Comparative Trials in Two Areas of High and Low Transmission in Uganda
Most malaria deaths occur within 48 hours of onset of symptoms, and in rural areas with poor access to health facilities, home management of malaria (HMM) can improve the timeliness of treatment and reduce malaria mortality by up to 50%. In order to maximize both coverage and impact, ACTs should be deployed in HMM programmes, as well as in formal health facilities. Up to 80% of malaria cases are treated outside the formal health sector and shops are frequently visited as the first (and in some cases only) source of treatment. Strategies to deploy ACTs in Africa thus also need to examine the role of shops in home management and to ensure that drugs sold are appropriate. The current practice of presumptive treatment of any febrile illness as malaria (both at health facilities and in the context of HMM) based solely on clinical symptoms without routine laboratory confirmation, results in significant over-use of antimalarial drugs. With ACT being a more costly regimen, it is important to be more restrictive in its administration and rapid diagnostic tests (RDTs) provide a simple means of confirming malaria diagnosis in remote locations lacking electricity and qualified health staff.
This study therefore proposes to evaluate the feasibility, acceptability, and cost-effectiveness of using RDTs to improve malaria diagnosis and treatment by community-based drug distributors.The accuracy of RDTs, and the acceptability of this approach, will be evaluated in both low and high transmission areas.
- Being tested
- Rapid diagnostic test, presumptive malaria treatment
- Keywords
- History of fever, measured fever
- Medical subject headings
- Fever, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid diagnostic testDevice
Use of rapid daignostic tests for diagnosis of malaria
presumptive malaria treatmentOther
Treatment of malariabased on clinical diagnosis without use of diagnostic test
| Study group | Role | What they receive |
|---|---|---|
| Rapid diagnostic test and treatment | Active comparator | Not described Receives: Device: Rapid diagnostic test |
| Treatment without rapid daignostic test | Other | Not described Receives: Other: presumptive malaria treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients given prompt effective treatment by CDDs: % of <5-year-old children diagnosed with malaria who receive appropriate ACT treatment within 24 hours of onset of malaria.
Measured: 36 months
Secondary outcomes (1)
Coverage of prompt effective treatment: % of <5-year-old children with fever who received ACT treatment within 24 hours of onset of malaria, measured through household surveys.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2010 (estimated)
- Study startMar 2010
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- DBL -Institute for Health Research and Development
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Uganda, London School of Hygiene and Tropical Medicine, Artemisinin-based Combination Therapy
- Responsible party
- Principal investigator, Pascal Magnussen, DBL -Institute for Health Research and Development
- Investigators
- Richard Ndyomugyenyi, MD, Principal investigator, Ministry of Health, Uganda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01048801
- Sponsor's protocol ID
- ACTUGA2
- Acronym
- ACTUGA2
- Status last verified
- Oct 2012
- First submitted
- 13 Jan 2010
- Last updated
- 12 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mbonye AK, Ndyomugyenyi R, Turinde A, Magnussen P, Clarke S, Chandler C. The feasibility of introducing rapid diagnostic tests for malaria in drug shops in Uganda. Malar J. 2010 Dec 21;9:367. doi: 10.1186/1475-2875-9-367.
PubMed 21176131Lal S, Ndyomugenyi R, Paintain L, Alexander ND, Hansen KS, Magnussen P, Chandramohan D, Clarke SE. Caregivers' compliance with referral advice: evidence from two studies introducing mRDTs into community case management of malaria in Uganda. BMC Health Serv Res. 2018 May 2;18(1):317. doi: 10.1186/s12913-018-3124-8.
PubMed 29720163
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role and Effectiveness of Rapid Diagnostic Tests in Home-based Management of Malaria: Comparative Trials in Two Areas of High and Low Transmission in Uganda
- ClinicalTrials.gov ID
- NCT01048801
- Acronym / sponsor ID
- ACTUGA2 / ACTUGA2
- Keywords
- History of fever, measured fever
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- DBL -Institute for Health Research and DevelopmentUniversity, hospital or other
- Collaborators
- Ministry of Health, Uganda, London School of Hygiene and Tropical Medicine, Artemisinin-based Combination Therapy
- Study start
- Mar 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 14 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Most malaria deaths occur within 48 hours of onset of symptoms, and in rural areas with poor access to health facilities, home management of malaria (HMM) can improve the timeliness of treatment and reduce malaria mortality by up to 50%. In order to maximize both coverage and impact, ACTs should be deployed in HMM programmes, as well as in formal health facilities. Up to 80% of malaria cases are treated outside the formal health sector and shops are frequently visited as the first (and in some cases only) source of treatment. Strategies to deploy ACTs in Africa thus also need to examine the role of shops in home management and to ensure that drugs sold are appropriate. The current practice of presumptive treatment of any febrile illness as malaria (both at health facilities and in the context of HMM) based solely on clinical symptoms without routine laboratory confirmation, results in significant over-use of antimalarial drugs. With ACT being a more costly regimen, it is important to be more restrictive in its administration and rapid diagnostic tests (RDTs) provide a simple means of confirming malaria diagnosis in remote locations lacking electricity and qualified health staff.
This study therefore proposes to evaluate the feasibility, acceptability, and cost-effectiveness of using RDTs to improve malaria diagnosis and treatment by community-based drug distributors.The accuracy of RDTs, and the acceptability of this approach, will be evaluated in both low and high transmission areas.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rapid diagnostic test and treatment | Active comparator | Device: Rapid diagnostic test |
| Treatment without rapid daignostic test | Other | Other: presumptive malaria treatment |
Who may qualify
- Ages
- 5 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged between 6 months and 5 years (< 5 years)reported with fever by the mother/ caretaker of the child
- Children with uncomplicated malaria/ fever episodes
- Children whose mothers consent to participate
Key exclusion criteria (3 listed)
- Children aged less 6 months or greater than 4 years (≥ 5 years)
- Children requiring referral to a health facility (severe malaria, complicated fever episode, convulsions/fits, loss of consciousness, and other danger signs)
- Children whose mothers refuse to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid diagnostic testUse of rapid daignostic tests for diagnosis of malaria | Device | Rapid diagnostic test and treatment |
| presumptive malaria treatmentTreatment of malariabased on clinical diagnosis without use of diagnostic test | Other | Treatment without rapid daignostic test |
Primary outcome
Proportion of patients given prompt effective treatment by CDDs: % of <5-year-old children diagnosed with malaria who receive appropriate ACT treatment within 24 hours of onset of malaria.
Time frame: 36 months
1 secondary outcome
Coverage of prompt effective treatment: % of <5-year-old children with fever who received ACT treatment within 24 hours of onset of malaria, measured through household surveys.
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2012.
- Results publication: PubMed 21176131Mbonye AK, Ndyomugyenyi R, Turinde A, Magnussen P, Clarke S, Chandler C. The feasibility of introducing rapid diagnostic tests for malaria in drug shops in Uganda. Malar J. 2010 Dec 21;9:367. doi: 10.1186/1475-2875-9-367.
- Derived from this study: PubMed 29720163Lal S, Ndyomugenyi R, Paintain L, Alexander ND, Hansen KS, Magnussen P, Chandramohan D, Clarke SE. Caregivers' compliance with referral advice: evidence from two studies introducing mRDTs into community case management of malaria in Uganda. BMC Health Serv Res. 2018 May 2;18(1):317. doi: 10.1186/s12913-018-3124-8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Ndyomugyenyi, MD principal investigator
Ministry of Health, Uganda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid diagnostic test and presumptive malaria treatment in people with Fever and Malaria, run by DBL -Institute for Health Research and Development at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients given prompt effective treatment by CDDs: % of <5-year-old children diagnosed with malaria who receive appropriate ACT treatment within 24 hours of onset of malaria. (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01048801, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2012.